The Food and Drug Administration (FDA) in the US has given the all clear for phase I trials of Antipotide(a potential new anti-obesity drug), having approved Arrowhead Research Corporation’s Investigational New Drug Application. Only recently did the journal Science Translational Medicine publish research about the success of the drug when administered to rhesus monkeys. This phase I trial will be carried out by researchers at the University of Texas and will commence shortly.

A phase I trial is the first human study of a particular drug and is carried out in order to gauge the metabolic and pharmacological action of the drug in human beings where only a small number of individuals are tested at first. Side effects and reactions to the increase in dose are observed along with how effective the drug is at Phase II of the process. Participants might be healthy or patients who require treatment although specific groups are usually excluded on safety grounds.

Antipotide works by targeting the blood vessels that supply blood to white fat tissue. In the animal study, substantial weight loss and a decrease in BMI and waist circumference were observed. It is very early days for Antoptide so do not expect this medication to get a license any time soon but we will keep you up to date with the drug’s progress.

Topiramate has been proven to be a successful weight loss drug for those who can tolerate the side effects that go with it according to the results of a meta-analysis of previously published studies which will be presented at The Endocrine Society’s 93^rd Annual Meeting in Boston. Topiramate is used in medicine as an anti-convulsant and for the prevention of migraines.

Data on 3,300 patients who were overweight were collected and those who were taking the drug for 4 months at least, lost on average 11.8 pounds more than those taking the placebo pills but evidence of the safety of the drug as a monotherapy for weight loss is non-existent at present. The length of time one takes the drug and the dosage is the decider when it comes to weight loss achieved.

The results show that a dosage of between 96 to 200mg per day and for duration of more than 28 weeks saw the best results in weight loss. Patients were 7 more likely to lose more than 10% of their original body weight. Side effects of Topiramate included burning around the mouth, strange tastes, slower cognitive abilities and a reduction in the ability to move. Concentration and memory were also affected.

Those who took part in the study were twice as likely to stop taking the treatment as a result of the side effects than those who were taking the placebo but the weight loss experienced by those who had tolerated the side effects was more impressive than other weight loss drugs that have tried to gain the approval of the FDA in recent years. We would not even consider prescribing this drug for weight loss without a wider safety study.

Following the results of meta-analyses of phase III drug trials, Arena presented its findings at the European Congress on Obesity and has demonstrated that Lorcaserin, its weight loss drug candidate, can help the obese shed up to one third of their original body weight. Lorcaserin was trialled as an appetite suppressant where an average of 5.8% of weight was lost by participants over a period of one year and in some cases 40% of weight was lost along with the reduction of harmful levels of cholesterol and blood pressure.

Last year the FDA (Food and Drug Administration) rejected Arena’s application for approval based on its potential to cause the growth of tumours in rats but the company feels confident that this should not have been a concern and is due to present evidence to support its position and next year, the company will seek the approval of the European regulator. If all goes well, it is hoped that the drug will be available from 2013.

The trials involved 7,500 people and it was revealed that 9 out of 10 of the participants noticed a certain amount of weight loss over the period of one year when taking Lorcaserin twice daily.

The drug was not found to be associated with any cardiovascular risk, the main reason other weight loss treatments have recently been taken off the market.

The MHRA (Medicines and Healthcare products Regulatory Agency) will be issuing a new herbal regulation at the end of the month. All herbal pills, products and supplements must be authorized for marketing before they are sold in Europe. Now customers can purchase herbal diet pills and supplements safe in the knowledge that they are approved and deemed safe to consume.

It is difficult for pharmaceutical companies to win the approval of the FDA (Food and Drug Administration) and European Medicines Agency for weight loss medications and while they are sent away to assess data and reports that take years to wade through in order to prove their creation as safe and efficacious, hundreds of dodgy diet pills, slimming pills and herbal devices that have not been approved for marketing are being sold like hotcakes in health shops and on the internet.

Sometimes it takes a complaint or two to raise the suspicions of the regulators and other times the products are tested at random. Often the regulators find that the “herbal” slimming pills have traces of drugs that are labelled prescription drugs and that are not fit for consumption without a full medical consultation and prescription. These traces and sometimes key ingredients can be highly dangerous when taken with other medications resulting in health complications such as cardiovascular illness and even death.

It is high time that the MHRA took control over this booming market and separated the supplements from the illegal substances that are putting lives at risk. Worryingly, an increasing number of such devices are being purchased since Reductil was voluntarily taken off the market by Abbott pharmaceuticals this year. It is more important than ever to make the existing market a safe one for frustrated customers who are desperate to find a successful weight loss treatment.

Vivus Inc has presented on the additional benefits of Qnexa at the American College of Cardiology suggesting that the pharmaceutical company might be closer than ever to gaining FDA (Food and Drug Administration) approval for its weight loss drug. The drug helped patients decrease their blood pressure and levels of cholesterol after 2 years of treatment.

Patient dependence on blood pressure lowering treatment decreased on average by 19% and blood triglycerides decreased by 26%. Furthermore, there were no new safety risks reported in the study comprising 675 participants.

As we have previously posted, the FDA sent Qnexa away last October due to concerns that the drug could potentially be linked with heart risk and birth defects. The FDA decided that before approving the drug they would have to see benefits other than pure weight loss and this most recent study appears to give the FDA what it wants.

Vivus said in January that information on the history of oral cleft in children whose mothers took topiramate (one of the ingredients of Qnexa) would need to be reviewed. In January they estimated that this research would take 6 months to complete and so it looks like Vivus is the closest to gaining approval among the competing pharmaceutical companies. Arena is reviewing data on cancer risk and its drug Lorcaserin and will present results to the FDA by the end of the year. Orexigen has been sent away to review the potential heart risks associated with its drug, Contrave but this information could take years to gather.

Previous studies reveal that patients lost 10% of their original body weight with Qnexa, proving its potential and putting it out ahead of Lorcaserin and Contrave, which both assisted patients in losing just over 5% body weight over a year.

The NHS Information Centre has published figures that show that prescriptions for weight loss pills have been on the rise over the last few years. In 2009 there were 1.5 million NHS prescriptions issued for diet pills and clearly a lot more were issued privately to patients who do not use the NHS. This information is not exactly shocking news but it has been jumped on by the likes of the Daily Mail with criticism of doctors doling out drugs at a huge cost to the NHS to provide a quick fix.

The total cost to the NHS was £47 million in 2009. This is not such a staggeringly large figure when you consider that obesity rates have increased from 7% in 1980 to 23% in 2009. British women are now officially the fattest in Western Europe and many (albeit a minority) are turning to their GPs for help. Anti-obesity medications are not handed out lightly and dieters need to demonstrate that they are losing weight before they are allowed to continue on the medication, which is pretty expensive.

We all know that a healthy diet and regular exercise are the best ways to lose weight and then maintain it at a healthy level but some people clearly need an extra boost and there is nothing wrong with that so long as they fulfil their side of the bargain and make the adjustments necessary to lose weight. If they don’t then they will not get a repeat prescription – it is as simple as that.

Xenical (orlistat) is the only diet pill that can be prescribed at the current time and it is anything but a quick fix. People will lose twice as much weight on this medication than by dieting alone but the weight loss is slow and steady – this is the best way to achieve a sustainable weight loss.

We know that it is easy to criticise doctors for handing out what are essentially lifestyle medications on the NHS and there is an argument to be advanced that these drugs should only be available privately but obesity is a huge problem because of all the associated risks that come along with it such as heart disease and diabetes and these issues will cost the NHS dear in years to come. What is incontrovertible however is the argument that patients must take responsibility for their weight and if they do not adapt their lifestyle to one more compatible with maintaining a healthy weight then they should be cut loose by the NHS in terms of prescriptions for expensive weight loss products.

Arena, the US pharmaceutical research company behind failed drug candidate Lorcaserin has announced that it is cutting 66 staff at its San Diego base in order to conserve cash and focus on getting Lorcaserin approved in the US. The FDA had rejected Lorcaserin because of concerns about tumours found in the breasts of female rats during phase 1 trials. The same issue was not replicated in the human trials but the FDA is understandably concerned to exclude the possibility that Lorcaserin would affect humans in the same way. There are a number of drugs that are already approved that produced the same results in trials on rodents that have not been replicated in humans so Arena is confident that it can meet these concerns. The FDA advisory committee was also concerned about potential depression and memory loss so these areas will also have to be addressed.

Although 2010 was not a great year for new obesity drug candidates, we do believe that they will fare better in 2011 – even if the year did not start well with the rejection of Contrave and the request for a full cardiovascular risk study. It is our view that both Lorcaserin and Qnexa will be licensed in 2011, filling the gap in the market left after the withdrawal if Sibutramine.

The head of France’s second largest pharmaceutical company, Servier, has been summoned to court after 2000 deaths have been linked to the company’s Mediator diet pills.

The drug was formally administered for diabetics who were overweight but became a very popular appetite suppressant after time. Jaques Servier launched the drug in the 70s and it was sold to five million people. It was taken off the market in Spain and Italy a decade before it was in France due to concerns over its safety.

The complaint against Servier states that he intentionally misled his customers about the drug including information on the ingredients. France’s health minister has since promised to reform the relationship between France’s drugs regulatory system and the pharmaceutical companies. It is approximated that between 500 and 2,000 people died as a result of the consumption of the drugs active ingredient, benfluorex, which is associated with heart valve damage. Victims are pressing charges against Mr. Servier for manslaughter.

California based pharmaceutical development company, Vivus, will have a busy month this January as they hope make progress with the FDA on their two leading drug candidates. Avanafil, a PDE5 inhibitor used in men suffering erectile dysfunction wows with 80% of men taking it achieving erections and two thirds able to have intercourse. In addition, it only takes 15 minutes for the drug to take effect unlike the other PDE5 inhibitors which can take up to an hour.

The approval of their promising weight loss drug, Qnexa, will also be discussed with US regulators this month. Recent trials have proved successful despite the FDA requiring more information. Vivus has submitted more detail on the associations between Qnexa and side effects such as birth defects and cardiovascular risk. Vivus is not a done deal yet but the company appears confident that they will get the green light in August without a pre-authorization cardiovascular risk study.

Long term trials for Avanafil have revealed great potential for the medication. The results released last week reveal that the treatment will work on a majority of its users and due to the speed with which it is metabolized it can be used twice a day without risk.

Vivus has announced their decision to ask the European regulators to approve Qnexa. Having been refused approval by the FDA in the United States due to their taking issue with possible risk regarding cardiovascular side effects and birth defects, the pharmaceutical company has stated that it has now addressed the concerns raised by the FDA and independent analysts expect this medication to be approved upon review. The European Medicines Agency will review Vivus’ application shortly.

Since the panel recommendation to approve Orexigen’s Contrave, the outlook for the future approval of weight loss drugs is a bit brighter. We would expect Lorcaserin to be approved as well, even although it was rejected earlier this year.

Arena Pharmaceuticals has received the news they were dreading. The FDA in the United States has rejected their obesity drug, Lorcaserin. The drug that presented before the panel in September, has failed to pass safety and efficacy standards of the organization. FDA announced that they were concerned about tumours found in the rats that were tested in the clinical trials and additionally, they described the drug as having limited benefits.

All of the mammary and lung tissues will now need to be looked at again and it must then be proved that the carcinogenicity of the drug would have an irrelevance in relation to a human risk assessment.

It may not be over for Lorcaserin if they can and will resubmit and disprove the concerns of the FDA regarding the efficacy of the drug.

There is a really great article in the Daily Mail today about diet pills. There are so many quack weight loss remedies on the market today and this article provides an unbiased critique from a state registered dietician. It is definitely worth a read.

As a regulated slimming clinic we understand that many people are desperate to lose weight and there is a whole unregulated industry out there ready to exploit them. The Online Clinic will normally only ever recommend prescription diet pills as they have been through clinical trials to demonstrate efficacy and safety. Occasionally things go wrong however and even licensed medications can be found to have detrimental side effects that are not outweighed by any clinical benefit. As we have reported on these pages, both Acomplia and Reductil have lost their licenses in the last few years. Whether or not Reductil really was safe for the patient group for whom it was intended is still up for debate but there is no real evidence that it was not safe for people without pre-existing cardiovascular risk but the regulators are not taking any chances on this one and Reductil has been withdrawn. The same is true for Acomplia. We know that this medication worked for some people and not for others and we were very careful not to prescribe it to anyone with psychiatric risk factors but the fact that some people committed suicide when on the medication is obviously something that is not acceptable and only became apparent in post license marketing.

The Daily Mail article comes out against all of the non-prescription diet pills available other than Alli, which contains Orlistat. The slimming aid that comes top of their survey is Xenical, which is the medication that we prescribe. Appesat gets a low score and this result accords with our experience of this treatment. We have had a lot of patients who have asked for Appesat but most (not all however) have not had great results with it. Appesat works as a bulking agent but only works when taken with a meal so it does not help with those mid-morning and afternoon snackers.

Until another medication comes along (and there are a few in the pipeline) then Xenical is going to be our diet aid of choice. For the record, this one got 8/10 in the Daily Mail survey.

The race is on for the most effective and safest anti-obesity drug. Abbott, the makers of Meridia (Sibutramine) and Arena, the makers of Locaserin, are going head to head in September at the FDA in the US. Abbot will present to an advisory panel of the US Food and Drug Administration who will be reviewing on-going post-authorization clinical studies into the controversial drug Sibutramine on September 15th. The following day, the same panel will review the clinical data on new drug candidate, Lorcaserin.

Sibutramine, also known as Reductil, was only taken from the shelves in January after the European Medicines Agency (EMA) recommended its suspension after a 6 year study which revealed that patients taking Sibutramine showed an increase in the risk of non-fatal cardio vascular events where there was a pre-existing cardiovascular problem. The problem with this study was that it concentrated on a population group actually contraindicated for sibutramine under the terms of its marketing authorisation, leading many experts to criticise the decision of the EMA. Abbott is confronting the regulators again and is hoping to generate a different sort of recommendation.

The Endocrinologic and Metabolic Drugs Advisory Committee will review Lorcaserin just one day after Abbott’s meeting with the FDA. It is anticipated that the result for Loracserin will be positive given that it appears to meet the benchmark criteria in terms of weight loss and the side effects appear to be minor. Also, unlike Qnexa, which got the thumbs down last month, Lorcaserin has been studied over two years. Lorcaserin, in its phase III of clinical testing, triumphed when 7% of both the Lorcaserin users and the placebo users stopped taking the treatment due to the experiencing of uncomfortable side effects.  Lorcaserin has the lowest discontinuation rates of any anti-obesity treatment.

Whilst we desperately need new treatments to help with the burgeoning problem of obesity, we need to make sure that the risks associated with taking any new drug do not outweigh the benefits.

An exciting time for Denmark based drug company 7TM Pharma, as they complete the first stage of clinical trials for the as yet unnamed drug molecule, TM38837. Likened to effective weight loss drugs of the past such as Acomplia, the drug will perform similarly but without the side effects once associated with other drugs from the same family.

TM38837 functions as a CB1 receptor blocker. This drug blocks the cannabinoid receptors which are responsible for the feeling of hunger. Such antagonists work directly on the central nervous system and in the past have been criticised for their harmful, psychological effects. Although blocking the same receptors as Acomplia once did, TM38837 does so without crossing the blood-brain barrier to any significant degree and instead concentrates on blocking receptors in the peripheral nervous system. This action is likely to eliminate the psychiatric side effects associated with Acomplia.

Rigorous clinical trials are being carried out and so far the results have been successful and out of 48 healthy adults tested, only 7 experienced mild side effects with a majority responding well. It will be this Autumn before the results of the next stage of clinical trials are available. If the trials are successful, this will finally be a major advancement for weight loss drugs.

The Food and Drug Administration in the US has removed the dietary food supplement, ‘Joyful Slim’ from the shelves following evidence that it contains the drug Sibutramine.

Rather surprisingly, an FDA panel has voted against approval of the proposed weight –loss drug Qnexa.

The vote, taken yesterday, was narrowly lost by 9 to 7. The panel said that though they believed that Qnexa was effective, they were worried about granting approval before several key safety concerns are resolved.

The panel agreed that the new medication does work better than any currently approved weight loss drug, enabling users to lose up to 14.7% of their body weight when used in conjunction with a diet and exercise program.

However they were concerned that the medication could potentially cause a series of side effects, including birth defects, an increased suicide risk and an increased risk of kidney stones.

Qnexa uses two medications which are already on the market, phentermine and the seizure drug topimirate. While both medications are approved separately, it seems that the panel were disturbed by how many people were projected to want to try the medication. Millions in America are obese and a large number of those are likely to want to try a new slimming pill, were it to be available.

The panel said that as the clinical trials lasted for only a year, it was ‘impossible to extrapolate the trial data to the wider population’, according to panel chair Kenneth Burman of Georgetown University.

While the FDA does usually follow the advice of their panel when deciding whether or not to grant approval for a new medication, they are not obliged to do so. The closeness of the vote made FDA Deputy Director of Endocrine Products, Eric Coleman, say in a news conference that there was a sense that a lot of people were hesitant over whether or not to give the drug the go-ahead.

Well, we seem to have missed something for a change. Apparently a new slimming pill was launched over the counter a couple of weeks ago and it sold out within 3 days – all 50,000 packs flew off the shelves.

The “new” treatment is called Capsiplex and it contains the active ingredient Methylcellulose. Methylcellulose has been available for a number of years and it is used to treat diarrhoea and constipation. You might think that it is a bit weird that the same medication is used to treat two diametrically opposed conditions but it will have different effects based on the amount of water that you drink. Methylcellulose has also been prescribed to treat obesity by acting as an appetite suppressant. We are not entirely sure how effective this has been but we are looking into offering this to patients of The Online Clinic. If we can get some reliable clinical data that would give us confidence that the treatment works then we will seriously consider offering as a treatment option.

At the current time only Xenical (orlistat) is available to prescribe as a diet pill and only Appesat is offered as an appetite suppressant. We were slightly sceptical about Appesat if the truth be known but we decided to give some patients the option of trying it and it seems to have been a success, with a number of repeat orders coming through already and we have only been offering it for two weeks.

We have seen a report today from researchers at Liverpool University who have been studying Zotrim – a weight loss pill that is deemed to be herbal (although we dispute this definition as it actually contains quite a bit of caffeine as well as a few plant extracts). Anyway, people taking Zotrim apparently are able to lose 11 pounds in one month compared with 1 pound for people taking a placebo. Zotrim has been designed to make the user feel fuller for longer and it apparently delays the time that it takes the stomach to empty by 20 minutes. The researchers also suggested that those taking the diet pill had a reduced incidence of sugar cravings – a pitfall for many dieters.

Longer term studies have however been less complimentary. A study by Which?, the consumer affairs organisation, has suggested that while people lose weight in the short term on this slimming pill, they actually put it all back on again. Zotrim can be purchased in most chemist stores and supermarkets in the UK. The Online Clinic does not supply weight loss pills that have not been through rigorous clinical trials to demonstrate safety and effectiveness so Zotrim is not available through our website.

There’s already a fair amount of excitement about new diet pill Qnexa after clinical trials showed it could be a very effective aid to weight loss. However it has now been suggested that not only could it help users shed the pounds, but also bring relief to gritted-teeth partners by curing snoring.

A six-month study in the U.S which involved 45 snoring patients has indicated that the medication can combat the desperately irritating condition.

Not only is snoring frustrating for any bedfellows, it can also  increase the risks of high blood pressure and heart disease, which are associated with obstructive sleep apnoea – a condition that causes snoring.

Snoring is caused by a narrowing of the airways, which relax as someone falls asleep. Most people just carry on sleeping through this, but for those with sleep apnoea the airways totally collapse, shutting breathing off for at least 10 seconds. This leads sufferers to awake with a jolt and a snore, though most do not remember this as they immediately return to sleep.

The condition is strongly associated with weight problems, as excess fat around the neck increases pressure on the upper airways. Weight loss can significantly help the problem.

It is therefore still unclear whether the drug, made from a combination of low doses of phentermine and topiramate, an epilepsy medication, helps due to the patients' weight loss experience, or whether there is another action that improves sleep. More research would need to be carried out involving patients who are not overweight but do suffer from sleep apnoea.

It has not been a good few years for anti obesity drugs. Acomplia (Rimonabant) was withdrawn from the market in October 2008 and in January 2010 Reductil (Sibutramine) had its marketing authorization suspended across the whole of the EU following the publication of some data that suggested that the drug could increase the risk of non-fatal cardiovascular events in patients with a pre-existing heart condition.

Officials in New York have announced that they shut down 72 websites illegally selling prescription-only slimming pills.

In the international operation Pangea II, which saw Interpol, U.S agencies and task forces in 2 dozen countries work together, 751 websites were monitored and 72 were shut down. Officials investigated over 16,000 packages of potentially counterfeit medication, leading to a haul of almost 167,000 counterfeit and illegal pills. These included not only diet pills but antibiotics and steroids.

In total, 22 people have been taken into custody to be questioned over the findings of the operation.

There are believed to be many websites operating on the internet which claim to sell genuine Reductil, Xenical and herbal pills, which have actually been stolen or manufactured in illegal factories. Both Reductil and Xenical should only be sold with a legitimate doctor’s prescription.

The investigators said that many of the slimming pills seized where thought to be placebos or contain dangerous levels of the active ingredient used in the genuine forms of the medication. They also warned that counterfeit pills were often cut with dangerous other substances.

Interpol Secretary-General praised the operation, saying that officials have proved that the internet is not an ‘anonymous safe-haven’ for those using it for criminal purposes.

The pharmaceutical firm Vivus have announced that data on their new diet pills Qnexa will be released today at the annual meeting of the European Association for the Study of Diabetes, which will be taking place in Vienna in Austria.

Last month Vivus published very promising phase 3 data taken from their two-year clinical trial. The results showed that Qnexa promoted weight loss, as well as causing patients to experience improvements in their blood sugar, blood pressure and lipid levels.

While the medication is already in stage III trials as a diet pill, Vivus also hope to receive FDA approval to market it as a diabetes medication. Diabetes and obesity are very closely linked and medical experts have warned that as obesity increases worldwide, so too will the numbers of people developing type 2 diabetes.

The data Vivus plan to share with the conference is specific to the diet pill’s potential for combating diabetes. They have already announced that the medication significantly reduces patients haemoglobin, an indicator of blood sugar levels and it is already known that weight loss can improve people’s risk factors for the illness.

The president of Vivus, Leland Wilson, said in a press statement that he believed Qnexa had the potential to play an important role in the treatment of diabetes in the coming years.

The market share price of the pharmaceutical company Vivus has soared after the company published promising results from its late-stage clinical trial into the new diet pill Qnexa.

The medication is a combination of two drugs, the epilepsy medication called topiramate and the weight-loss drug phentermine. This was previously a popular diet pill but fell out of favour with doctors and specialists after effectiveness and safety concerns.

The Phase III trials showed that patients taking the medication lost a significant proportion of their body weight and also showed a reduction in their blood pressure, likelihood of developing type 2 diabetes and fat levels.

The trials were randomised. One involved 1,267 morbidly obese patients and the other involved 2,487 patients who were overweight or obese and had other health problems like diabetes or high blood pressure.

After a year of taking part in the trial, patients taking the medication at the highest dose lost 10.4% of their body weight on one trial and 11% on the other, compared with 1.6% to 1.8% amongst those taking the placebo. After taking into account the placebo effect this added up to weight loss of 9%, well surpassing the 5% the FDA demands for approval for a new diet pill to be approved.

Further FDA benchmarks were met when 70% of patients taking the drug lost at least 5% of their body weight, compared to 20% taking the placebo. The FDA say that at least twice as many patients taking a medication as those taking a placebo must lose at least 5%. However about 40% of those taking the high dose did not complete the year of treatment so this could be significant.

Vivus, based in California, say they plan to ask for FDA approval next year. We are not sure at this stage if the company is going to seek approval in the EU as phentermine has had a problematic history with the European Medicines Agency. 

A Scottish shipping firm has become the centre of an international investigation into the sales of diet pills.  The company they were working with is now being investigated by trading standards in the UK, as well as officials abroad.

Phytoscience, a pharmaceuticals distribution company, started working with Trading Planet Ltd in May. Since that time customers have been complaining in their hoards about an offer that seemed to promise a £1 trial of ‘Life Cleanse’ and ‘Acai Berry’ products. They failed to see in the small print that it contained a clause allowing Trading Planet to continue to send them further batches of the diet pills for £79 if they failed to cancel the agreement within 15 days.

Phytoscience said they have received many complaints from angry customers as their warehouse address was given as the return address. Their director, Chris Swainson, even said he had been sent rude letters to his home after furious consumers tracked him down.

He said that Trading Planet, who are believed to operate from Spain, are one of 12 clients. Phytoscience promised that if the deal was proved to be a scam they would ‘drop them like a hot potato’ but said that if they were working legally, they would continue to work with them.